BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR

    MDR report key: 7005781 · Received November 7, 2017

    Report

    Report Number
    3002953813-2017-00038
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 13, 2017
    Report Date
    January 23, 2018
    Manufacturer
    NEUROTHERM, INC
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED STARTUP FAILURE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED STARTUP FAILURE COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE WHILE THE PATIENT WAS PREPPED, THE UNIT WAS TURNED ON AND DISPLAYED A WHITE SCREEN BUT NEVER DISPLAYED THE WELCOME SCREEN. THE GENERATOR POWER CABLE WAS DISCONNECTED AND THE GENERATOR WAS POWERED ON BUT THERE WAS NO RESOLUTION. THE PROCEDURE WAS CANCELLED AND THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786600 3 LESION NT1100¿ PAIN MANAGEMENT RF GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD NEUROTHERM, INC RFG-NT-1100

    Patients

    Seq Age Sex Outcome Treatment
    1